Recon: Pfizer, BioNTech raise 2021 vaccine output to 2.5B doses; FDA rejects Keytruda in early breast cancer

• The operation formerly known as Warp Speed: Biden leans heavily on the flagship Trump-era initiative (STAT)
• Pfizer raise 2021 vaccine output goal to 2.5B doses (Reuters) (Endpoints) (FT)
• Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light (Fierce)
• Biden urged to keep patent protections for Covid vaccines (FT)
• FDA snubs Keytruda in early breast cancer after harsh review as Merck looks to next data analysis (Fierce) (Endpoints)
• House Democrats target HHS 'sunset' rule with Congressional Review Act (The Hill)

• Canada pauses AstraZeneca COVID-19 vaccine use for those under 55, wants new risk analysis (Reuters)
• Germany to recommend AstraZeneca shot only for over 60s: media (Reuters)
• Biggest share of Indian-made vaccines for poor country programme stays in India (Reuters)
• India extends shelf life of AstraZeneca vaccine - document, source (Reuters)
• Asian countries seek vaccine supplies after India export curbs hit COVAX (Reuters)
• Austria in talks to buy a million doses of Russia's Sputnik V vaccine (Reuters)
• Novavax COVID-19 vaccine could be approved by UK in April, Evening Standard says (Reuters)
• Amarin's heart drug Vazkepa gets European Commission approval (Reuters)
• Novartis says Kesimpta gets EU approval in multiple sclerosis (Reuters) (Press)
• Roche, Novartis approvals in Europe signal more head-to-head competition (Reuters) (Press)
• Canadian company pursues compulsory license to distribute Covid-19 vaccine to low-income countries (STAT)
• BioNTech owners in talks to invest in German cancer labs group: sources (Reuters)

• CureVac taps Swiss contract drugmaker Celonic for COVID-19 vaccine production (Reuters)
• Brazil regulator says Bharat Biotech vaccine does not meet factory standards (Reuters)
• U.S., China positive on pandemic treaty idea: WHO's Tedros (Reuters)
• Humanigen says its drug keeps Covid patients off ventilators. But are some data missing? (STAT)
• Mali approves Russia's Sputnik V vaccine - Russian sovereign wealth fund (Reuters)
• Pakistan to import Chinese Cansino COVID vaccine in bulk to package 3 million doses locally: minister (Reuters)

• Novartis and Genentech push for clarity from FDA on how disease progression models can be used for regulatory decisions (Endpoints)
• A CRISPR 2.0 pioneer, expecting credit on its own invention, is ruffled by a competitor (STAT)
• Oxford Nanopore picks London for latest tech IPO (FT)
• Takeda taps BridGene to pursue hard-to-drug neurodegenerative disease targets (Fierce)
• Wave culls leading Huntington's meds as shares go under after rival Roche hit by similar fate (Fierce) (Endpoints)
• After Pfizer cancer deal, Pyxis Oncology nabs a hefty $152M series B (Fierce)
• EU recommendations for 2021-2022 seasonal flu vaccine composition (EMA)
• Armed with Pfizer's ADC platform, Pyxis scores $152M round to shoot for the clinic while taking its time on I/O programs (Endpoints)
• The IBD market is set to soar to $32B. AbbVie could be the big winner, but there's meat left on the bone — top analyst (Endpoints)
• Going head-to-head with Merck on I/O, Genentech vets raise fresh round and enter clinic (Endpoints)
• Inctye’s Pemazyre authorised in the EU for bile duct cancer (PharmaTimes)
• Flagship startup Omega takes lead 'epigenomic controller' candidate closer to the clinic with new $126M round (Endpoints)
• After tackling Covid-19 with AstraZeneca, Oxford's Jenner Institute is hard at work on a different kind of vaccine (Endpoints)
• Forma sees data 'supporting' sickle cell therapy dosing levels; LianBio teams with Tarsus for eye irritation in China (Endpoints)
• U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine (Press)
• Novartis dives even deeper into radioligands, notching licensing deal with iTheranostics for multiple compounds (Endpoints) (Press)
• Japan Gives Up on Setting New Generic Target by March as Manufacturing Scandals Weigh (PharmaJapan)
• MHLW Panel Approves List of “Stable Supply Medicines”; Pricing to Become Topic of Discussions (PharmaJapan)

• FDA panel to probe Endologix, broader stent graft safety in Q4 (MedtechDive)
• Boston Scientific pads case for radioactive microspheres with liver cancer survival win (Fierce)
• Full results of EndeavorRx adjunct trial show longer benefits with or without stimulant therapy (mobihealthnews)
• NMPA publishes revised Chinese medical device regulations (Emergo)
• Merck sets up $240M Alydia Health buyout to beef up its future Organon women's health spinout (Fierce)
• EU approval for new AI technology that can predict heart attacks (PharmaTimes)

• Pfizer, BioNTech Call IP Suit A 'Burden' On Vaccine Effort (Law360)
• Arthrex Cleared Of Infringing TriMed Patent After Bench Trial (Law360)
• Opioid MDL's Tribal Bellwether Dodges Early Drug Co. Attacks (Law360)
• A Mixed R&R From The Abilify MDL (Drug & Device Law)